Claims (15)
1. Pripravak koji sadrži CD19xCD3 bispecifično protutijelo za uporabu u postupku za liječenje tumorske mase tkiva limfnih čvorova i/ili ekstranodalnog limfoma uzrokovanog difuznim limfomom velikih B stanica (DLBCL) kod pacijenta koji je refraktoran na liječenje kemoterapijom i/ili u relapsu nakon liječenja kemoterapijom, pri čemu se pripravak primjenjuje u kombinaciji s glukokortikoidom.1. A preparation containing a CD19xCD3 bispecific antibody for use in a procedure for the treatment of a tumor mass of lymph node tissue and/or extranodal lymphoma caused by diffuse large B cell lymphoma (DLBCL) in a patient who is refractory to chemotherapy treatment and/or in relapse after chemotherapy treatment, whereby the preparation is used in combination with a glucocorticoid.
2. Pripravak za uporabu prema patentnom zahtjevu 1, naznačen time što tkivo limfnih čvorova uključuje limfne čvorove i/ili slezenu.2. Preparation for use according to patent claim 1, characterized in that the lymph node tissue includes lymph nodes and/or the spleen.
3. Pripravak za uporabu prema patentnom zahtjevu 1, naznačen time što ekstranodalni limfom uključuje središnji živčani sustav (CNS), kožno tkivo, dojku, pluća, jetru, gastrointestinalni trakt, genitourinarni trakt, tkivo oka, koštanu srž i/ili kosti.3. The preparation for use according to claim 1, characterized in that the extranodal lymphoma includes the central nervous system (CNS), skin tissue, breast, lung, liver, gastrointestinal tract, genitourinary tract, eye tissue, bone marrow and/or bones.
4. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time što se prva doza pripravka primjenjuje tijekom prvog vremenskog razdoblja i uzastopno se primjenjuje druga doza pripravka tijekom drugog vremenskog razdoblja, pri čemu druga doza premašuje prvu dozu.4. A preparation for use according to any one of claims 1 to 3, characterized in that the first dose of the preparation is administered during the first time period and a second dose of the preparation is successively administered during the second time period, wherein the second dose exceeds the first dose.
5. Pripravak za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time što navedena prva doza iznosi između 1 i 15 µg/m2/d.5. Preparation for use according to any of the previous patent claims, characterized in that the specified first dose is between 1 and 15 µg/m2/d.
6. Pripravak za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time što navedena druga doza iznosi između 15 i 60 µg/m2/d.6. Preparation for use according to any of the previous patent claims, characterized in that said second dose is between 15 and 60 µg/m2/d.
7. Pripravak za uporabu prema patentnom zahtjevu 4, naznačen time što obuhvaća primjenu nakon prve i druge doze tijekom prvog i drugog vremenskog razdoblja treće doze pripravka tijekom trećeg vremenskog razdoblja.7. The preparation for use according to patent claim 4, characterized in that it comprises administration after the first and second doses during the first and second time periods of the third dose of the preparation during the third time period.
8. Pripravak za uporabu prema patentnom zahtjevu 7, naznačen time što treće vremensko razdoblje premašuje prvo i drugo vremensko razdoblje, pri čemu druga doza premašuje navedenu prvu dozu.8. Preparation for use according to patent claim 7, characterized in that the third time period exceeds the first and second time periods, wherein the second dose exceeds the specified first dose.
9. Pripravak za uporabu prema patentnom zahtjevu 7 ili 8, naznačen time što treća doza premašuje prvu i drugu dozu.9. Preparation for use according to claim 7 or 8, characterized in that the third dose exceeds the first and second doses.
10. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 7 do 9, naznačen time što navedena prva doza iznosi između 1 i 15 µg/m2/d, te je poželjno 5 µg/m2/d.10. Preparation for use according to any one of patent claims 7 to 9, characterized in that the stated first dose is between 1 and 15 µg/m2/d, and preferably 5 µg/m2/d.
11. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 7 do 10, naznačen time što navedena druga doza iznosi između 1 i 15 µg/m2/d, te je poželjno 15 µg/m2/d.11. Preparation for use according to any one of patent claims 7 to 10, characterized in that said second dose is between 1 and 15 µg/m2/d, and preferably 15 µg/m2/d.
12. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 7 do 11, naznačen time što navedena treća doza iznosi između 15 i 60 µg/m2/d, te je poželjno 60 µg/m2/d.12. Preparation for use according to any one of patent claims 7 to 11, characterized in that said third dose is between 15 and 60 µg/m2/d, and preferably 60 µg/m2/d.
13. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time što se tijekom liječenja protutijelo dozira u konstantnoj dozi odabranoj iz skupine koja se sastoji od 5 µg/m2/d, 15 µg/m2/d ili 60 µg/m2/d, te je poželjno 60 µg/m2/d.13. Preparation for use according to any one of claims 1 to 3, characterized in that during the treatment the antibody is dosed in a constant dose selected from the group consisting of 5 µg/m2/d, 15 µg/m2/d or 60 µg/ m2/d, and preferably 60 µg/m2/d.
14. Pripravak za uporabu prema patentnom zahtjevu 1, naznačen time što je glukokortikoid odabran iz skupine koja sadrži najmanje jedan od kortizona, kortizola, kloprednola, prednizona, prednizolona, metilprednizolona, deflazakorta, fluokortolona, triamcinolona, deksametazona, i betametazona, flutikazon propionata, triamcinolonacetonida, pri čemu je poželjan deksametazon.14. Preparation for use according to patent claim 1, characterized in that the glucocorticoid is selected from the group containing at least one of cortisone, cortisol, cloprednol, prednisone, prednisolone, methylprednisolone, deflazacort, fluocortolone, triamcinolone, dexamethasone, and betamethasone, fluticasone propionate, triamcinolone acetonide , with dexamethasone being preferred.
15. Pripravak za uporabu prema patentnom zahtjevu 14, naznačen time što se glukokortikoid daje prije primjene CD19xCD3 bispecifičnog protutijela.15. Preparation for use according to patent claim 14, characterized in that the glucocorticoid is administered before the administration of the CD19xCD3 bispecific antibody.